FDA 510(k)

CystoSure Plus 캡슐터

K-번호: K181346 · 2018-08-06

결정일2018-08-06

제품 코드EZL

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

CystoSure Plus Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Emmy Medical, LLC. It received FDA 510(k) clearance on 2018-08-06 under 510(k) number K181346. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CystoSure Plus Catheter?

CystoSure Plus Catheter is a medical device that received FDA 510(k) clearance on 2018-08-06. The listed applicant is Emmy Medical, LLC. The 510(k) number is K181346.

When did CystoSure Plus Catheter receive FDA 510(k) clearance?

CystoSure Plus Catheter received FDA 510(k) clearance on 2018-08-06, under 510(k) number K181346.

Who is the listed applicant for CystoSure Plus Catheter?

The FDA 510(k) record lists Emmy Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CystoSure Plus Catheter?

The FDA product code for CystoSure Plus Catheter is EZL.

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CystoSure Plus 캡슐터

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: EZL)

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